NCT07469332

Comparison of the Effects of Moderate- and High-Dose Glucocorticoids on Postoperative Recovery

Comparison of the Effects of Moderate- and High-Dose Glucocorticoid Administration on Postoperative Recovery: A Prospective Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Laparoscopic cholecystectomy is a commonly performed minimally invasive surgical procedure; however, postoperative pain, nausea, and delayed recovery remain clinically relevant problems. Glucocorticoids such as dexamethasone are widely used in perioperative care for the prevention of postoperative nausea and vomiting and as part of multimodal analgesia strategies. This prospective randomized controlled trial aims to compare the effects of moderate- and high-dose intravenous dexamethasone administered intraoperatively on postoperative recovery in patients undergoing elective laparoscopic cholecystectomy. The primary outcomes include postoperative nausea and vomiting, inflammatory markers (CRP and WBC), and Quality of Recovery-15 (QoR-15) scores. Secondary outcomes include postoperative pain scores, intraoperative remifentanil consumption, postoperative opioid consumption, and adverse events.

Detailed description

Laparoscopic cholecystectomy is one of the most commonly performed minimally invasive surgical procedures worldwide. Although it is associated with shorter hospital stay and faster recovery compared with open surgery, patients frequently experience postoperative pain, nausea, and delayed functional recovery. Effective perioperative strategies aimed at improving recovery and reducing postoperative complications remain an important component of enhanced recovery protocols. Glucocorticoids, particularly dexamethasone, are widely used in perioperative care due to their anti-inflammatory, antiemetic, and analgesia-sparing properties. Perioperative dexamethasone administration has been shown to reduce postoperative nausea and vomiting (PONV) and may contribute to improved pain control and overall recovery. However, the optimal dose of dexamethasone for maximizing recovery outcomes while maintaining safety remains unclear. This prospective randomized controlled study is designed to evaluate whether higher doses of intraoperative dexamethasone provide additional benefits in postoperative recovery compared with moderate doses or placebo in patients undergoing elective laparoscopic cholecystectomy. Patients undergoing elective surgery will be randomly assigned to receive either moderate-dose dexamethasone, high-dose dexamethasone, or placebo as part of perioperative management. All patients will receive standardized anesthesia management and multimodal analgesia according to institutional practice. Postoperative recovery will be evaluated using patient-reported recovery quality scores, inflammatory markers, and commonly assessed clinical outcomes including postoperative nausea and vomiting, pain intensity, and analgesic requirements. The findings of this study may help clarify the dose-response relationship of perioperative dexamethasone and provide evidence to guide optimal dosing strategies aimed at improving postoperative recovery after laparoscopic cholecystectomy.

Conditions

• Postoperative Recovery
• PONV

Interventions

Type	Name	Description
OTHER	Saline (0.9% NaCl)	Intravenous normal saline 4 mL administered intraoperatively to S group
PROCEDURE	TAP Block	Oblique subcostal TAP block is administered to all groups
DRUG	moderate dose Dexamethasone	Intravenous dexamethasone administered intraoperatively at 0.1 mg/kg (D1)
DRUG	High dose dexamethasone	Intravenous dexamethasone administered intraoperatively at 0.2 mg/kg (D2; maximum 20 mg).

Timeline

• Start date: 2026-03-30
• Primary completion: 2026-07-30
• Completion: 2026-07-30
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: Turkey (Türkiye)